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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020706
Company: NOVARTIS

Products on NDA 020706

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMADINE	EMEDASTINE DIFUMARATE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020706

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020706_emadine_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2003	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20706slr011_emadine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20706slr011ltr.pdf
12/04/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/16/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/20/1999	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/17/1999	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
09/28/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/04/1998	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/04/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020706

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2003	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20706slr011_emadine_lbl.pdf

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